Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-20.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2025 – 20 May 2025 | Human Drugs | Clean | |
| 11 Feb 2019 – 26 Feb 2019 | Human Drugs | 483 | View 483 → |
| 13 Nov 2017 – 5 Dec 2017 | Human Drugs | 483 | View 483 → |
| 13 Jul 2015 – 17 Jul 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Feb 2019
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Robert J Martin
5 Dec 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Robert J Martin, Delaram Moshkelani
5 Dec 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Robert J Martin, Delaram Moshkelani
Investigators
FDA investigators tied to this site in the record.
Robert J Martin2 insp.
Erik W Koester1 insp.
Delaram Moshkelani1 insp.
Saied A Asbagh1 insp.
Unnee Ranjan1 insp.
Arie Menachem1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ipsen Bioscience, Inc.'s 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat